BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIOFIX 2 TITANIUM CLAMP 20MM

    MDR report key: 3883104 · Received February 19, 2014

    Report

    Report Number
    2916714-2014-00102
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    November 28, 2013
    Report Date
    February 18, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GXN
    PMA / PMN Number
    K972332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MANUFACTURING SITE EVALUATION: THE CRANIOFIX HAS BEEN ANALYZED MACROSCOPICALLY. IT CAN BE CLEARLY SEEN THAT THE PIN HAS BEEN CUT OFF TOO SHORT WHERE THERE ARE NO MORE ANTI-SLIP SERRATIONS. THE CUTTING IS ALSO NOT PERPENDICULAR TO THE PIN, BUT SLIGHTLY SLOPED. THE CORRESPONDING SIDE OF THE CRANIOFIX EXHIBITS DAMAGE TO THE FINS WHERE THE TWO PLATES HAVE BEEN COMPRESSED PRIOR TO CUTTING. THE PINS ARE ALSO NOT EQUALLY DEFORMED. THE CAUSE FOR THE LOOSENING OF THE PLATE IS THAT THE PIN HAS BEEN CUT TOO SHORT. ROOT CAUSE IS USER ERROR.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). CASE OF FRONTOTEMPORAL CRANIOTOMY; THE DISKS WERE COMING OFF. WHEN THE CUSTOMER TRIED TO CLOSE THE CRANIAL BONE USING THIS PRODUCT, THE DISKS OF THIS PRODUCT WERE COMING OFF. OPERATION DELAYED OVER 15 MINUTES. CUSTOMER CLAIMS: HANDLING AND THICKNESS OF CRANIAL BONE WERE CORRECT. BECAUSE THE CRANIAL BONE WAS FIXED PROPERLY AT THE SAME POINT USING ANOTHER FF492T.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103869 CRANIOFIX 2 TITANIUM CLAMP 20MM GXN AESCULAP AG & CO. KG FF492T 51947823

    Patients

    Seq Age Sex Outcome Treatment
    1 Other